Jobs · Analyst · Maryland

Scientist

GAP Solutions, Inc. · Gaithersburg, MD · Yesterday
On-siteAnalystFull-time

Duties And Responsibilities

  • Work with Lab Operations group to optimize lab environment to maximize efficiency and reduce risk of product contamination or loss.
  • Cookinate with other project members to ensure timelines and material production requests are met.
  • Develop mRNA-Lipid nanoparticle vaccines, through microfluidic and impingement jet mixing devices:
    • Purify research-phase recombinant proteins, virus vaccines and or virus-like particles in support of other groups at the VRC
    • Support technology transfer of processes to VRC Pilot Plant for manufacture of clinical product including authoring process descriptions, reports, and on-floor support.
    • Develop novel techniques protocols for process development, including high-throughput and/or robotics-based methods.
    • Perform protein small molecule conjugation experiments to support method develop mentor conjugate-based vaccine candidates.
  • Author training documents, instrument SOPs, and other equipment supporting documentation.
  • Author process documents to support toxicology lot production including batch records and process summary reports.
  • Analyze and compile data, present at various group department meetings.
  • Support the Purification group of the Vaccine Production Program VPP Labs of the Vaccine Research Center.
  • Develop downstream purification processes or recombinant proteins, virus vaccines, and virus-like particles VLP that may be used as clinical vaccine candidates.
  • Serve as a functional point of contact in chromatography process development unit operations.
  • Provide critical process step assessment and experimental design to define optimal process parameters for chromatography unit operations.
  • Train group members in large-scale unit operation such as AxiChrom column packing and Pilot-scale chromatography execution.
  • Perform protein-small molecule conjugation experiments to support method develop mentor conjugate-based vaccine candidates.
  • Facilitate consortium authorship efforts in project-specific technical reports and protocols.
  • Operate, calibrate, or maintain equipment used in quantitative or qualitative analysis, such as spectrophotometers, calorimeters, flame photometers, or computer-controlled analyzers.
  • Maintain laboratory equipment.
  • Operate laboratory equipment to analyze samples.
  • Operate microfluidic mixer for lipid nanoparticle development studies.
  • Clean Equipment
  • Work products and documents related to developing downstream processes for recombinant proteins, virus vaccines, and virus-like particles (VLP) that could be used as clinical vaccine candidates; serving as a functional point of contact in either chromatography or filtration (normal flow and tangential flow filtration) purification process steps for a given project.
  • Work products and documents related to working with the Group members to design, develop and optimize purification process for all clinical trial vaccine candidates.
  • Work products and documents related to writing and reviewing technical protocols and reports; purifying research-phase recombinant proteins, virus vaccines and/or virus-like particles in support of other groups at the VRC.
  • Work products and documents related to developing novel techniques/protocols for process development, including high-throughput and/or robotics-based methods.
  • Work products and documents related to performing protein/small molecule conjugation experiments to support method development or conjugate-based vaccine candidates; analyzing and compiling data, present at various group/department meetings.
  • Meet with lab members to present updates.

Qualifications

  • Bachelor's degree in Biochemistry, Molecular Biology, Microbiology, Chemistry, or related field.
  • Minimum of 5 years of relevant laboratory experience in biopharmaceutical manufacturing, preferably in vaccine development.
  • Experience with chromatography, filtration, and microfluidic mixing technologies.
  • Strong understanding of protein purification techniques and process development.
  • Excellent communication and collaboration skills.
  • Ability to work independently and as part of a team.

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